A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

Plaque Psoriasis Clinical Trial

— EGFR  

Official title:

A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01566578
• Other study ID #: EGFR-Study
• Status: Recruiting
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: August 2, 2012
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: August 2012
• Source: Ennar Pharmaceuticals AF
• Contact: Michael Weisskopf, MD
• Email: michael.weisskopf[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application

• EGFR immunohistochemistry score > 5

• Male

• Age 18-60 years

Exclusion Criteria:

• Systemic psoriasis treatment 3 months prior and during the study

• Local psoriasis treatment on the investigational sites in the last 30 days or during the study

• Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type

• Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants

• History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis

Intervention

Drug:
• Human recombinant epidermal growth factor
topical

Other:
• Placebo cream
Dermal cream without EGF

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Dermatology Clinic	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Ennar Pharmaceuticals AF	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in EGFR density in epidermis of psoriasis lesion	Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66.; EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).	Day 66	No
Secondary	Change to baseline in target lesion severity score (PASI)	A blinded dermatologist assesses the treated psoriasis plaque clinically using the lesion assessment part of the PASI score, assessing 3 qualities (thicknes, redness and scaling) of the lesion. Score ranges from 0 (absent) to 4 (very severe), resulting in a total score of 0 to 12 (3 x 4)	Day 80	No
Secondary	Change to baseline in histological feature: thickness of the epidermis	Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.; A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.	Day 66	No
Secondary	Number of participants with adverse events	At every visit the patients are asked about the occurence of adverse events. The last visit is on day 80. All adverse events will be recorded in the crf.	Day 80	Yes
Secondary	Change to baseline in the histological feature: acanthosis	Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.; A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.	Day 66	No
Secondary	Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates	Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.; A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.	Day 66	No